The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

March 31, 2009 updated by: University of Western Ontario, Canada

The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study

The purpose of this study is to determine the impact of a regular course of treatment with Hyaluronic acid (HA) injections on gait in knee osteoarthritis (OA) patients. Three consecutive HA injections will be compared to three consecutive placebo injections to determine whether HA's analgesic effect is greater than that of a placebo injection, and to observe whether HA's viscoelastic properties are manifested in a human knee OA population. We hypothesize that HA injections will relieve pain to a greater extent than placebo injections in knee OA patients, and will afford them with improved walking characteristics, such as increased walking speed, and step length.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Knee osteoarthritis (OA) is a severely debilitating disease associated with stiffness and pain in the knee joint, and with a loss of function. Hyaluronic acid (HA) injections are incorporated into non-surgical standard of care for knee OA patients and have been proven to relieve pain in patients who have not received symptomatic relief with other knee OA interventions. HA allows synovial fluid to act as a lubricant and shock absorber for joints, and although this is encouraging ground to advocate for the use of HA treatment in knee OA patients, these properties have yet to be proven in a controlled clinical trial setting. Therefore, we are undertaking this study to observe whether the physiological adaptation in the OA knee joint, initiated by HA injection, will result in biomechanical improvements in human knee OA patients, specifically walking mechanics.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • St. Joseph's Health Care, Parkwood Hospital, Aging Rehabilitation and Geriatric Care research center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 60 - 80 years old.
  • Mild to moderate knee osteoarthritis:
  • Clinical diagnosis (symptoms).
  • Radiographic diagnosis (Kellgren-Lawrence grade I - III).
  • Must provide provide informed consent and knowledge of all possible benefits and possible adverse events.
  • Available for duration of the study.
  • Not taking any other knee osteoarthritis medications during the study.

Exclusion Criteria:

  • Non - OA arthritides.
  • Hip, ankle, or foot OA.
  • End stage OA.
  • Lower back/extremity pathology.
  • Previous surgery on knee affected by OA (except arthroscopy within the past 12 - 18 months).
  • Neurological/Cardiovascular gait impairment.
  • Pregnant.
  • Cognitively impaired.
  • Not available for duration of study.
  • Taking other knee OA medications at time of study.
  • Gastro-intestinal disturbance.
  • Avian allergy or any other contraindication to intra-articular injections with Hyaluronic acid.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: HAG
Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart.
Device: Hyaluronic acid
3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.
Other Names:
  • Sodium Hyaluronate
  • Suplasyn
PLACEBO_COMPARATOR: PG
Those patients that receive 3 consecutive placebo injections one week apart.
Device: Placebo (Saline injection)
3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.
Other Names:
  • Saline injection
  • Sham injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gait analysis with GAITRite software.
Time Frame: Baseline; after each injection; 3 and 6 months post treatment.
Baseline; after each injection; 3 and 6 months post treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
WOMAC OA index (pain, stiffness, function); Six minute walk test (function).
Time Frame: Baseline; after each injection; 3 and 6 months post treatment.
Baseline; after each injection; 3 and 6 months post treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Ontario, Canada

Investigators

  • Study Director: Joseph E DeCaria, BA, MSc('09), The University of Western Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ANTICIPATED)

May 1, 2009

Study Completion (ANTICIPATED)

May 1, 2009

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 22, 2008

First Posted (ESTIMATE)

October 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2009

Last Update Submitted That Met QC Criteria

March 31, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB#: 14017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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